October 1, 2015

My Script for FDA

I wish I could tell you what I actually said at FDA's Labeling Workshop. Bellow is the script I worked up. I am at my best when I get up and channel the material and just go with it. It like speaking in tounges or something. The only conscious thought I am aware of when it is happening is to not say "um."I was off this script by about word 3 but it does, I think, and hope, reflects what I said.I can tell you that whatever I said, I was well received by individuals participating in the workshop from both FDA and industry. I felt respected and did my very best to contribute relevant patient comments to the proceedings and do so with good humor.It was a privilege to be invited to represent patients and people with diabetes. As some point, the transcripts will surface and the truth will come out. 'Till then this is my story and I am sticking with it.

Hi, I am Bennet Dunlap. My wife and I have four kids, Let me brag here - Two are out of college, have jobs and insurance! Two live with type 1 diabetes and have done so since the were 7 and 9. Like 28 or 9 million Americans, I live with type 2 diabetes.

After 3 decades as a banker, I apologize for what I did to the American Economy it was clearly all my fault, I earned master's degree in health communication to serve as an advocate for people with diabetes.
Since I am the first patient here, maybe I can back up and talk a little about what patients want from devices to inform what we want from labeling. It is relevant.

We want to be SAFE. We want the devices to help us be healthy. Ideally while keeping us both safe and healthy devices don’t add too much of an additional burden to our lives.
LABELS help keep us safe; They tell us how to use a device. What we should used it for. How to find help, and what to do if it doesn't work right.
People are going to look for help. Ideally the correct information is easy to find. If not, we will look in other places and, to be honest, some of us are dummies.

We are going to find help when we need it and look for the friendliest way to do that. That friendly place should be the official label. To do that maybe write like you would to a friend and not the plaintiff in a legal proceeding. And no 6 point font some of us have trifocals. (wave glasses to room)

Devices and their instructions are drivers of healthy actions.
Many, devices drive of self-care, including medication dosing.
Diabetes is a great example, PWD use devices to manage and treat daily. For millions of American, including my children, that management includes calculating insulin doses multiple times a day.

Look at that picture. See the meter. It says 110. What you don't see is that The tolerance is +/-20% 95% of the time. 95% of the time means 5% it may be off in the weeds. My kids test and take insulin about five times a day, 365 days a year so that 1800 doses of insulin 5% is 90 doses a year bases off reading outside +/- 20%.

The reality is not ONE meter, sold to patients for self-management use in the USA, is APPROVED to dose insulin. Not one. Yet millions of people like my kids do it EVERY DAY.

What a device is labeled to do matters. There has been one meter approved, that I know of, that was specifically labeled NOT to be used to dose insulin or calibrate a Continuous glucose meter,

We need to flip that around. Labels should explicitly say what a device is to be used for. What it is for is as important as what it is not for to be used for. And that "to be used for" needs to keep up with real world dynamics. So if it is for dosing insulin - say so.

Labels should reflect reality, we do dose insulin, and those devices that are accurate enough to do so should say so.

Technology advances, everywhere but the USA the standard is now +/- 15%. When FDA puts new guidelines out the old stuff should not be allowed to continue to be used to dose insulin and the new device labeling is a tool to do that.

The Patient's job is to use the devices to stay healthy, not figure out which is living up to its approved performance. We can't do that. FDA should enforce labeling. Peer reviewed studies show there are meters that fail to live up to the +/- 20% 95% of the time

Failing to deliver promised accuracy is Device Regulations VW. The Scientific Journals make it clear there are devices failing to deliver +/- 20%. Even when FDA ups the guidance to something new, these VW TDI of the glucose meter world will be no the road - that is approved and for sale. Some insurance buyers who look the only price will continue to select them over more competent devices. I fear this will include Medicare. My question here is intended use labeling if it doesn't get the VW TDI OFF THE MARKET?

Other things will go wrong.

Look things go wrong.
I saw a FACEBOOK Avatar picture of A PWD's that said ERR 5. A very common message that meant the meter didn't get enough blood. Things wrong enough that we can joke about it.

Patients need to know where to go to get help and where to go if the if the help doesn't.{pause}. help…. We need to know how to report errors - So error can be fixed.

If you listen to patients, you hear a lot of stories of calling a device company and being told a device error is the patient's fault. It may well be, some of the time, but the strong feeling is some device companies doesn't report errors because they choose to see the error as the customer's fault. Nobody is perfect if a company has no device error reports that is a bright red flag that they are far from perfect.

FDA has an app for that. I’m a smart enough guy. I struggle with the app. When we talk about better labels a constantly easy app would help - a lot.

We patients need consistent, easy to use, instructions on what to do to report so FDA can use the reports. By consistent I meant manufacturers can't double talk it, personally I am for dictated language by FDA on error reporting. Including what information makes the report useful and how to file it outside of the company's reporting structure. The ethical companies are reporting already; one has to wonder about the VW of the medical device world.
Failing to report is a safety issue.

I took the JAMA numbers and the Journal of Managed care’s cost estimates and it over a half billion. I was a banker $640 million is almost real money. - Mostly seniors so we are all paying for that via Medicare.

But enough of my silly rants, I felt it would be useful to survey people with diabetes, quick biased poll.
The top 8

Quotes from the survey:

Think about who your end users are - it may include children, and granted parents will likely be there helping them, but sometimes it's a school nurse who does not have extensive Diabetes device expertise. Almost anyone should be able to pick up the instructions and "get it" with relative ease.I know it is impractical, but after the first few months of using the devices, I don't look at the printed information. Can there be a way to cut out the cost of printing labels on " refills”?Please don't use this as an excuse to increase packaging or costs.I get very frustrated when I have pump sets coming with HUGE manuals every time I buy them